SUMADAN WASH- sulfacetamide sodium and sulfur cream SUMADAN- sulfacetamide sodium and sulfur kit

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

sulfacetamide sodium (UNII: 4NRT660KJQ) (sulfacetamide - UNII:4965G3J0F5), sulfur (UNII: 70FD1KFU70) (sulfur - UNII:70FD1KFU70)

Tilgjengelig fra:

Medimetriks Pharmaceuticals Inc.

INN (International Name):

sulfacetamide sodium

Sammensetning:

sulfacetamide sodium 90 mg in 1 g

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash is not to be used by patients with kidney disease.

Produkt oppsummering:

Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash is available in a Net wt. 16 oz. (454 g) bottle, NDC 43538-190-16. Sumadan® KIT contents one unit of Sumadan® Wash , Net wt. 16 oz. (454 g) and one unit of Rehyla® Wash, 16 oz. bottle, NDC 43538-191-16. Store at controlled room temperature 15°- 30° C (59°- 86° F). Protect from freezing. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. To report SUSPECTED ADVERSE REACTIONS , contact Medimetriks Pharmaceuticals, Inc., at 1-973-882-7512 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Autorisasjon status:

unapproved drug other

Preparatomtale

SUMADAN WASH- SULFACETAMIDE SODIUM AND SULFUR CREAM
SUMADAN- SULFACETAMIDE SODIUM AND SULFUR
MEDIMETRIKS PHARMACEUTICALS INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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SUMADAN
(SODIUM SULFACETAMIDE 9% & SULFUR 4.5%)
WASH
R ONLY
In a Moisturizing
Novasome
Vehicle
DESCRIPTION
Sodium sulfacetamide is a sulfonamide with antibacterial activity
while sulfur acts as a keratolytic
agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl)
sulfonyl]-acetamide, monosodium salt,
monohydrate. The structural formula is:
Each mL of SUMADAN (SODIUM SULFACETAMIDE 9% & SULFUR 4.5%) WASH
contains 90 mg of sodium
sulfacetamide and 45 mg of sulfur in a formulation consisting of:
butylated hydroxytoluene, C12-15
alkyl benzoate, caprylyl glycol, cetyl alcohol, cholesterol,
chrysanthemum dendranthema, dimethicone,
disodium oleamido MIPA sulfosuccinate, edetate disodium, ethylene
brassilate, glyceryl stearate,
hexylene glycol, lemon oil, magnesium aluminum silicate, magnesium
chloride, magnesium nitrate,
methylchloroisothiazolinone, methylisothiazolinone, niacinamide,
nonoxynol-20, octoxynol-5, purified
water, PEG-100 stearate, phenoxyethanol, propylene glycol, sodium
cocoyl isotheionite, sodium
methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, xanthan
gum.
CLINICAL PHARMACOLOGY
The most widely accepted mechanism of action of sulfonamides is the
Woods-Fildes theory, which is
based on the fact that sulfonamides act as competitive antagonists to
para-aminobenzoic acid (PABA), an
essential component for bacterial growth. While absorption through
intact skin has not been determined,
sodium sulfacetamide is readily absorbed from the gastrointestinal
tract when taken orally and excreted
in the urine, largely unchanged. The biological half-life has
variously been reported as 7 to 12.8 hours.
The exact mode of action of sulfur in the treatment of acne is
unknown, but it has been r